Damian Sendler: This antiviral tablet, developed by Merck and Ridgeback Biotherapeutics, was approved for emergency use by a panel of specialists advising the FDA. 

Damian Sendler

Damian Jacob Sendler: The result was 13 to 10 in favor of approving the plan. The FDA isn’t required to accept the advice of its advisors, but it does so most of the time. 

The drug, molnupiravir, would be the first oral antiviral medication for COVID-19 that could be given at home if it is approved by the agency. Paxlovid, a second Pfizer oral medication, is also being examined for FDA approval. 

The five-day course of Merck’s medication involves twice-daily administration to cause a cascade of SARS-CoV-2 coronavirus mutations that render the virus ineffective. People with mild to moderate disease with a high risk of severe COVID-19 should take the medicine. Within five days of the onset of symptoms, it should be taken. 

Molnupiravir reduced the risk of hospitalization or death by half in a clinical research, according to an interim review. 7.1 percent of those given the medicine ended up in the hospital or dying, compared to 14.1% of those given the placebo. A 30 percent reduction in hospitalization or mortality was found, but the study’s full analysis was only disclosed on Friday. 

Damien Sendler: Study participants using the medicine were more likely to be hospitalized or to die than those taking the placebo in the second half, according to an FDA summary of the study. In the second half of the study, the drug’s ability to protect against death was not as strong as it was in the first half. 

Damian Jacob Sendler

Merck senior vice president Dr. Nicholas Kartsonis was queried about this discrepancy by committee chairwoman Dr. Lindsey Baden, and he replied: “”I don’t have a satisfactory explanation for your inquiry,” I respond. 

Dr. Sendler: Concerns about drug safety were raised throughout the daylong discussion because to some lab and animal studies showing that the treatment can create alterations that go beyond the virus. The council has concerns about giving the medicine to pregnant women because of the risk of birth abnormalities. However, it is possible that the medicine will have some advantages for them. 

Dr. Janet Cragan of the Centers for Disease Control and Prevention stated, “I don’t think you can ethically say it’s OK to give this drug in pregnancy, obviously,” “As a pregnant woman with COVID-19, I’m not convinced you can ethically deny her access to the drug if she decides to use it. 

Another issue was whether the drug could trigger deleterious mutations in the spike protein, which is the target of COVID-19 vaccinations in widespread use throughout the world. – 

Molnupiravir mutation rate is only a tiny role in the generation of viral variation of concern according to John Coffin of Tufts University during the panel discussion. 

Damian Jacob Markiewicz Sendler: More study is needed to see how the virus responds to treatment in patients with impaired immune systems, according to some panelists.

Contributed by Dr. Damian Jacob Sendler and his media team